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Sexually Transmitted Infections Among African American Women Who Have Sex With Women (WSW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01043081
Recruitment Status : Completed
First Posted : January 6, 2010
Last Update Posted : May 11, 2016
Sponsor:
Collaborators:
Mississippi State Department of Health
University of Alabama at Birmingham
Information provided by (Responsible Party):
Leandro A. Mena, University of Mississippi Medical Center

Tracking Information
First Submitted Date January 4, 2010
First Posted Date January 6, 2010
Last Update Posted Date May 11, 2016
Study Start Date February 2009
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 4, 2010)
Prevalence rates of sexually transmitted infections [ Time Frame: 18 Months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 4, 2010)
Associated sexual risk behaviors [ Time Frame: 18 Months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sexually Transmitted Infections Among African American Women Who Have Sex With Women
Official Title Prevalence Rates of Sexually Transmitted Infections and Sexual Risk Behaviors Among African American Women Who Have Sex With Women
Brief Summary The purpose of this study is to determine the rates of sexually transmitted infections (STI) among a group of African American women who have sex with women (AA WSW). The first study hypothesis is that AA WSW are at risk for acquiring and transmitting STI, including the human immunodeficiency virus (HIV). The second study hypothesis is that AA WSW participate in multiple high-risk sexual activities that may facilitate transmission of STIs, including HIV.
Detailed Description

Historically, women who have sex with women (WSW) have been thought to be at low risk for acquiring sexually transmitted infections (STI), presumably due to the absence of genital mucosal contact present during vaginal-penile sex or due to the assumption that the vaginal mucosa experiences a lesser degree of trauma during female sex than during heterosexual sex. This assumption has been challenged and debated over the past two decades. In addition, the sexual health risks of WSW are only beginning to be understood.

To date the majority of research regarding STI in women has occurred in heterosexuals. National and local surveillance data that estimate the risk for STI transmission between WSW are limited, especially among African Americans. This is a group of women that may exhibit distinctive behavioral characteristics that may put them at higher risk for sexually transmitted infections STI and HIV than their Caucasian counterparts. This group of women has traditionally been reluctant to discuss their sexual orientation with physicians for fear of being stigmatized. The burden of STIs, including HIV, experienced by this group of women is largely unknown.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Endocervical and vaginal secretion specimens are being retained for future research studies in this field of sexually transmitted diseases.
Sampling Method Non-Probability Sample
Study Population The study population is African American women, aged 18 or above, who present to the Crossroads Clinic (STD Clinic) in the Jackson, MS metropolitan area for STI screening/evaluation who have engaged in sexual contact with another woman within the past 6 months.
Condition
  • Sexually Transmitted Infections
  • HIV Infections
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 4, 2010)
300
Original Estimated Enrollment Same as current
Actual Study Completion Date June 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Female
  • Age 18 years or older
  • African American race
  • Sexual contact with another female within the past 6 months
  • Ability to give written informed consent

Exclusion Criteria:

  • Male
  • Age less than 18 years old
  • Race other than African American
  • No sexual contact with another woman within the past 6 months
  • Pregnant
  • Prior enrollment in this study
  • Participants who, for any reason, in the opinion of the investigator, do not have the ability to give written informed consent or may not be expected to comply with the requirements of the protocol
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01043081
Other Study ID Numbers 2008-0143
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Data will only be shared with investigators
Responsible Party Leandro A. Mena, University of Mississippi Medical Center
Study Sponsor University of Mississippi Medical Center
Collaborators
  • Mississippi State Department of Health
  • University of Alabama at Birmingham
Investigators
Principal Investigator: Leandro A Mena, MD, MPH University of Mississippi Medical Center
PRS Account University of Mississippi Medical Center
Verification Date May 2016